Daiichi Sankyo, Merck Launch Phase III Trial Evaluating Safety, Efficacy of Ifinatamab Deruxtecan in Patients with Relapsed Small Cell Lung Cancer

August 1, 2024

By Don Tracy, Associate Editor

Daiichi Sankyo and Merck have commenced the IDeate-Lung02 Phase III clinical trial, which aims to compare the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) vs. physician’s choice of chemotherapy in patients with relapsed small cell lung cancer (SCLC) following disease progression with only one prior line of platinum-based chemotherapy. According to both companies, the initiation of the trial was based on results from a subgroup analysis of the IDeate-PanTumor01 Phase I/II trial of ifinatamab deruxtecan, which was presented at the 2023 World Conference on Lung Cancer.¹

“Patients living with small cell lung cancer face poor outcomes with currently available treatments,” said Mark Rutstein, MD, global head, oncology clinical development, Daiichi Sankyo, in a press release. “The IDeate-Lung02 trial is an important next step as we look to better understand the role of ifinatamab deruxtecan as a potential new medicine for patients with certain types of small cell lung cancer.”

The global, multicenter, randomized, open-label IDeate-Lung02 trial is expected to enroll a total of 460 patients across Asia, Europe, Oceania, North America and South America. The trial will randomly assign patients to receive either ifinatamab deruxtecan 12 mg/kg or physician’s choice of chemotherapy, which will include amrubicin, lurbinectedin, and topotecan. The primary endpoints of the study are objective response rate (ORR) as assessed by blinded independent central review, and overall survival. Secondary endpoints are ORR as assessed by investigator, progression-free survival, duration of response, disease control rate, and time to response.

In a joint statement, the companies explained that SCLC accounts for 15% of all lung cancer cases and is known for its aggressive nature and rapid progression to metastasis. Currently, five-year survival rates are only at 3%, with 65% of SCLC tumors expressing the protein B7-H3. B7-H3 is classified as a transmembrane protein that binds to the CD28 family of receptors that includes PD-1. While the protein has been shown to be overexpressed in a number of cancer types, its overexpression in SCLS has been associated with poor prognosis. Currently, there are no B7-H3 directed medicines approved for the treatment of any cancer.¹

According to the Cleveland Clinic, around 57 in 100,000 people in the United States will develop lung cancer in their lifetime, with non-small cell lung cancer being more common than SLCS.2 By the end of 2024, the American Cancer Society estimates that there will be 234,580 new cases of lung cancer with 125,070 deaths. The chance of a male developing lung cancer is one in 16 while women have a one in 17 chance.³

“The initiation of the IDeate-Lung02 trial for ifinatamab deruxtecan marks the second pivotal study since the start of our collaboration with Daiichi Sankyo and follows the recent initiation of the REJOICE-Ovarian01 Phase II/III study for raludotatug deruxtecan,” said Marjorie Green, MD, SVP, head of oncology, global clinical development, Merck Research Laboratories, in the press release. “This is a significant milestone as we work together to evaluate an innovative medicine that may have the potential to make a meaningful difference in the lives of people facing small cell lung cancer, a difficult-to-treat cancer.”

Daiichi Sankyo and Merck first entered into a partnership last October, with the goal of jointly developing patritumab deruxtecan, ifinatamab deruxtecan, and raludotatug deruxtecan. Moving forward, Daiichi Sankyo will focus on manufacturing and supply independently.¹

References

1. IDeate-Lung02 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Patients With Relapsed Small Cell Lung Cancer. Merck. August 1, 2024. Accessed August 1, 2024. https://www.merck.com/news/ideate-lung02-phase-3-trial-of-ifinatamab-deruxtecan-initiated-in-patients-with-relapsed-small-cell-lung-cancer/

2. Small Cell Lung Cancer. Cleveland Clinic. Accessed August 1, 2024. https://my.clevelandclinic.org/health/diseases/6202-small-cell-lung-cancer

3. Key Statistics for Lung Cancer. American Cancer Society. Accessed August 1, 2024. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html

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